Sterility Assurance Lead

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via: 
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and 
Partnership – Leveraging our collective expertise to connect people to products and services. 
 

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

The Sterility Assurance Lead plays a pivotal role in ensuring the sterility of injectable products through robust contamination control and sterility assurance strategies. This role extends beyond microbiological testing to encompass comprehensive oversight of aseptic manufacturing, contamination risk management, and adherence to global regulatory requirements. It involves close collaboration across departments to drive sterility assurance initiatives while fostering a culture of quality excellence.

Key Responsibilities

Every day, we rise to the challenge to make a difference and here’s how the Sterility Assurance Lead will make an impact:

• Driving Sterility Assurance Strategy:

  • Developing and implementing comprehensive sterility assurance frameworks, including contamination control strategies aligned with Annex I and global GMP guidelines.

  • Conducting risk assessments for aseptic processes, environmental monitoring, and container closure systems to mitigate contamination risks.

  • Leading initiatives to continuously improve aseptic techniques, gowning practices, and operational controls in sterile manufacturing environments.

• Oversight of Environmental Monitoring and Contamination Control:

  • Managing and optimizing the environmental monitoring program, ensuring it effectively supports aseptic manufacturing and mitigates contamination risks.

  • Investigating out-of-specification results in environmental monitoring, identifying root causes, and implementing corrective actions to prevent recurrence.

  • Overseeing the implementation and effectiveness of contamination control measures, including cleaning and disinfection practices.

• Support for Sterility-Related Validations and Audits:

  • Leading the scheduling and oversight of aseptic process simulations (media fills) and providing guidance during report reviews and approvals.

  • Validating and revalidating sterility-related test methods and aseptic processes to ensure compliance and robustness.

  • Representing the sterility assurance function in internal and external audits, addressing observations related to sterility, and driving responses and actions.

• Leadership and Collaboration:

  • Leading a multidisciplinary team to achieve sterility assurance objectives, providing training on aseptic and contamination control principles.

  • Working cross-functionally with Quality, Manufacturing, and Engineering teams to ensure alignment on sterility assurance requirements.

  • Acting as a key advisor to manufacturing teams, supporting investigations and CAPAs for sterility-related deviations.

  • Lead investigations at microbiology to ensure that appropriate root cause is identified and appropriate corrective actions are implemented.

• Documentation and Reporting:

  • Approving and maintaining documentation, including SOPs, validation protocols, contamination control plans, and trend reports.

  • Organize a site wise sterility Assurance Program and meetings with site SLT to showcase current trends and proposed actions.

  • Tracking and reporting sterility assurance performance metrics to identify areas for improvement and enhance contamination control strategies.

• Instrument and System Management:

  • Supporting the qualification of isolators, and other equipment within the laboratory.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• A Bachelor’s degree (or higher) in Microbiology or a closely related field (e.g., Biotechnology).

• This is senior role, therefore extensive years of experience in sterility assurance, aseptic manufacturing, or a related field, with a strong emphasis on microbiology and contamination control is needed.

• Aseptic Process Expertise:

  o   Proven experience in contamination control strategies, including cleaning and disinfection validation.

  o   Hands-on experience with isolator technology, environmental monitoring, and aseptic processing validations.

• Deep understanding of Annex I, US, and EMA GMP regulations and their application in sterility assurance

• Hands-on experience in regulatory audits, with a solid track record of compliance and audit readiness in sterile environments.

• Strong ability to mentor and develop teams, lead investigations, and drive sterility assurance initiatives.

• Risk Assessment & Problem-Solving: Experience in sterility-related risk assessments, deviation investigations, and implementing corrective/preventive actions.

• Technical Proficiency: Proficient in the use of contamination control tools and monitoring systems, including MODA, Excel, and project management software.

• Communication & Collaboration: Excellent ability to articulate sterility assurance concepts and collaborate cross-functionally to drive compliance and process improvements

This is a senior role that requires an in-depth understanding of microbiological principles as they apply to sterility assurance. You will play a critical role in ensuring the highest standards of aseptic manufacturing, contamination control, and compliance across our production processes. If you have a microbiology background and bring extensive hands-on experience in sterility assurance, we’d love to hear from you.

Benefits at Viatris

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:

• Excellent career progression opportunities

• Work-life balance initiatives

• Bonus scheme

• Health insurance

• Pension

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. 

Viatris is an Equal Opportunity Employer.